Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Wei Guo, Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier:
NCT01425736
First received: August 19, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with conventional definitive chemotherapy might improve the rate of disease control (RDC), progression-free survival (PFS),and overall survival in patients with recurrent and/or metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently no standard treatment approach, we designed this trial to test this hypothesis.


Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Drug: Chemotherapy
Drug: Nimotuzumab and Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Shanghai 9th People's Hospital:

Primary Outcome Measures:
  • Rate of Disease Control (RDC) [ Time Frame: 4years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity, progression-free survival (PFS), and overall survival (OS). [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: January 2009
Study Completion Date: March 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Chemotherapy

Chemotherapy

:Docetaxel(75mg/m²,1 time/21d, 2times,on days 1,22);Cisplatin(75mg/m²,1 time/21d, 2 times,on days 1,22,);Fluorouracil(750mg/m²/d,5times/21d, 10times)

Drug: Chemotherapy
Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 2times,on days 1,22);Cisplatin(75mg/m²,1 time/21d, 2 times,on days 1,22,);Fluorouracil(750mg/m²/d,5times/21d, 10times)
Other Names:
  • Docetaxel
  • Cisplatin
  • Fluorouracil
Experimental: Nimotuzumab and Chemotherapy

Nimotuzumab treatment:(200mg/w,6weeks );

Chemotherapy treatment: Docetaxel(75mg/m²,1 time/21d, 2times,on days 1,22);Cisplatin(75mg/m²,1 time/21d, 2 times,on days 1,22,);Fluorouracil(750mg/m²/d,5times/21d, 10times),Nimotuzumab treatment:(200mg/w,6weeks ).

Drug: Nimotuzumab and Chemotherapy

Nimotuzumab treatment:(200mg/w,6weeks );

Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 2times,on days 1,22);Cisplatin(75mg/m²,1 time/21d, 2 times,on days 1,22,);Fluorouracil(750mg/m²/d,5times/21d, 10times)Nimotuzumab treatment:(200mg/w,6weeks );

Other Names:
  • Docetaxel
  • Cisplatin
  • Fluorouracil
  • Nimotuzumab

Detailed Description:

Eligible patients were randomly assigned by using permutated blocks designed11 for each site to receive either Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen (Arm A) or docetaxel-cisplatin-fluorouracil alone regimen (Arm B). Combination arm chemotherapy was as conducted as follows. Since day 1, Nimotuzumab (200 mg, given as a 2-hour intravenous infusion before chemotherapy, Biotech Pharmaceutical Inc., Beijing, China) was administrated 1 h before chemotherapy once a week for two successive courses, followed by docetaxel (at a dose of 75 mg per square meter of body-surface area) was administered as a 1-hour intravenous infusion, followed by intravenous cisplatin (75 mg per square meter), administered during a period of 0.5 to 3 hours. After completion of the cisplatin infusion, fluorouracil (1000 mg per square meter per day) was administered as a continuous 24-hour infusion for 4 days. Patients in arm A received docetaxel-cisplatin-fluorouracil only.One treatment cycle comprised a period of 3 weeks (21 days). Patients received two cycles in both treatment arms, unless disease progression or unacceptable toxicity was observed. Patients in the experimental group who had at least stable disease could choose to continue maintenance Nimotuzumab every week until disease progression, intolerable toxicity, or study withdrawal.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Joined the study voluntary and signed informed consent form
  • Age 18-75,both genders.
  • Had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
  • At least one lesions can be measured,Conventional measurements ≥2cm, computed tomography(CT) examination ≥1cm .
  • Eastern Cooperative Oncology Group(ECOG) Performance Scale 0-2.
  • Life expectancy of more than 3 months.
  • Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
  • Haemoglobin≥90g/L ,White blood cell(WBC) ≥3×10^9/L
  • Hepatic function:ALAT、ASAT< 2.5 x ULN, TBIL< 1.5 x ULN
  • Renal function: Creatinine < 1.5 x ULN

Exclusion Criteria:

  • Received other anti EGFR monoclonal antibody treatment
  • Participation in other interventional clinical trials within 1 month
  • Previous received other drug or operative treatment within 6 month
  • Pregnant or breast-feeding women
  • History of serious allergic or allergy
  • Patients with the history of Serious lung or head disease
  • Other malignant tumor
  • not primary tumor(except for primary tumor therapy>3months)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425736

Locations
China, Guangdong
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
China, Jiangsu
Institute of Stomatology of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Wuxi People's Hospital; Nanjing Medical University
Wuxi, Jiangsu, China, 214000
Xuzhou Central Hospital of Xuzhou city,Dongnan University
Xuzhou, Jiangsu, China, 221009
China, Shanghai
9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Wei Guo
Sun Yat-sen University
Investigators
Study Chair: Wei Guo, MD, PhD, DDS Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
  More Information

No publications provided

Responsible Party: Wei Guo, Guo Wei, Shanghai 9th People's Hospital., Shanghai 9th People's Hospital
ClinicalTrials.gov Identifier: NCT01425736     History of Changes
Other Study ID Numbers: BT-IST-SCCHN-008
Study First Received: August 19, 2011
Last Updated: January 31, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai 9th People's Hospital:
Nimotuzumab
Chemotherapy
Head and Neck Squamous Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014